Validation Partners
Validation Partners, Inc. is a privately held U.S. healthcare consulting firm that provides software validation, SOP development, system implementation, and data conversion services to blood banks, transfusion services, and hospital laboratories requiring FDA regulatory compliance.
- Company typePrivate
- Founded1997
- HeadquartersRonkonkoma, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Validation Partners does
Validation Partners, Inc. is a privately held U.S. consulting firm headquartered in Ronkonkoma, New York, that provides software validation, technical writing, system implementation, project management, and data conversion services exclusively for healthcare organizations operating blood banks, transfusion services, and donor rooms. The firm validates laboratory and blood-bank software systems from vendors such as Wyndgate, SCC, Cerner, and Mediware, helping clients meet FDA regulatory requirements through test plan development, test script writing, script execution, and comprehensive documentation delivered in paper, CD-ROM, and video formats. The company also develops and adapts Standard Operating Procedures (SOPs) and provides on-site staff training with intentionally small class sizes of 5-6 people.
The business operates on a professional services revenue model with customized, contact-based pricing quoted directly through phone and email. Sales are conducted through enterprise field outreach led by the President and senior staff, supplemented by participation in industry events such as the AABB Annual Meeting and CTTXPO. The company's differentiators center on deep domain expertise: every staff member has a minimum of 10 years of laboratory and medical software experience, the President has over 20 years, and staff are personally screened for relevant blood bank and donor room operational experience.
Validation Partners serves a narrow set of large enterprise healthcare clients, with publicly named customers including Memorial Sloan Kettering Cancer Center, North Shore University Hospital at Manhasset, and M.D. Anderson Cancer Center. The firm is founder-led by President Janet Molny and operates as a small, privately controlled consulting business with no disclosed venture capital or institutional investment. A 2013-introduced Document Delivery System represents the most recent product surface expansion, while the bulk of the business remains centered on traditional validation documentation and implementation services.
Validation Partners firmographics
Firmographics- Name
- Validation Partners
- Legal name
- Validation Partners, Inc.
- Website
- https://validationpartners.com
- Company type
- Private
- Founded year
- 1997
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Validation Partners, Inc. is a privately held U.S. healthcare consulting firm that provides software validation, SOP development, system implementation, and data conversion services to blood banks, transfusion services, and hospital laboratories requiring FDA regulatory compliance.
- Ownership category
- akta.pro rank
Validation Partners industry classification
Industry- Product category
- Healthcare Software Validation Services
- NAICS
- Other Scientific and Technical Consulting Services (54169), Custom Computer Programming Services (541511)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)
- akta.pro secondary industries
- Blood Bank/Transfusion Medicine LIS (HLACAMAE), Data Management, Reporting & Regulatory Submissions for Central Labs (HLAGAEAL)
Keywords
Where Validation Partners is headquartered
LocationHeadquarters
- HQ city
- Ronkonkoma
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Validation Partners business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Validation Services: Comprehensive validation services for laboratory and blood bank software including test plan development, script writing, and script execution. Services available individually or as a complete package.
- Project Management Services: Project management assistance for information system implementations, including timeline development, resource allocation, and monitoring.
- Data Conversion Services: Database extraction, conversion, and migration services including legacy data archival and validation of converted data in new systems.
- System Implementation and Training: Implementation services including on-site training, with class sizes limited to 5-6 people, and validation consulting for in-house validation execution.
- Technical Writing and SOP Development: Creation and revision of Standard Operating Procedures, technical manuals, and documentation adapting to system changes.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Validation Partners product offering
Product offeringCore offering
Validation Partners provides software validation, implementation, and consulting services for laboratory and blood bank information systems used by healthcare organizations. The core Total Validation Services offering covers test plan development, test script writing, and execution with comprehensive documentation, complemented by project management, data conversion, system implementation with training, SOP development, and technical writing services.
Product overview
Validation Partners provides laboratory and blood bank software validation and consulting services. The company's core offering is Total Validation Services, which encompasses test plan writing, test script writing, and test script execution, supported by comprehensive documentation including paper records and video recordings. This core service is complemented by Technical Writing Services (SOP development and manual creation), System Implementation Services (with project management and training), Data Conversion Services (database extraction, conversion, and archiving), and a Document Delivery System. The company specializes in validating software products including Wyndgate, SCC, Cerner, and Mediware systems for transfusion and donor services operations.
Differentiator
Problem solved
Functional benefit
Products and services
- Total Validation Services
Companies that use Validation Partners
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
Validation Partners technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Validation Partners partnerships and signals
Strategic signalScale indicators2 records
Recent moves3 records
Expansion highlights3 records
Validation Partners competitors and assessment
Company assessmentDirect peers
- ProPharma Group: Provides GxP compliance consulting, computer system validation, and quality assurance services to pharmaceutical, medical device, and laboratory clients. Comparable to Validation Partners' regulatory validation and SOP development offerings.
- BioTechLogic: Life sciences consulting firm offering CSV, regulatory compliance, and quality services for laboratories and regulated software environments. Directly analogous to Validation Partners' GxP validation focus.
- ValSource: Validation and compliance consultancy specializing in commissioning, qualification, and computer system validation for pharmaceutical and laboratory operations. Overlapping service mix with Validation Partners in CSV and SOP development.
- CSols: Specialist GxP/CSV (computer system validation) consulting firm serving regulated laboratories and life sciences organizations. Directly comparable to Validation Partners in delivering validation, compliance documentation, and data integrity services under FDA frameworks.
Broad incumbents
- MasterControl: Established eQMS / quality management software provider serving life sciences manufacturers and labs. Broader incumbent offering validation-adjacent capability through productized QMS, competing indirectly with Validation Partners' manual CSV services.
- Sysmex America: Major diagnostics and laboratory information systems vendor serving hospitals and blood banks in the U.S. Larger incumbent in the blood-bank LIS category Validation Partners validates.
- IQVIA Laboratories / Q² Solutions: Large-scale central and specialty laboratory operator with extensive regulatory and data management capabilities for clinical trial and healthcare laboratory services. Adjacent incumbent serving similar blood-bank/lab customers with end-to-end services.
- Haemonetics (BloodTrack / SafeTrace): Blood management solutions provider offering SafeTrace Tx (formerly Mediware) and BloodTrack, which Validation Partners explicitly validates. Larger incumbent whose vendor-led validation services could compete with Validation Partners.
Emerging players
- Novatek International: Provider of electronic quality management and validation lifecycle software (eLIMS, eVal) for regulated laboratories. Comparable niche player offering software-enabled alternatives to manual CSV work.
- Blue Mountain Quality Resources: Provider of regulated asset management and quality management software (including for GxP environments). Adjacent to Validation Partners as a software-led alternative to manual validation services.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks3 records
Key highlights5 records
Customer concentration
Validation Partners social profiles
Digital presenceValidation Partners financial estimates
Financial estimateRevenue estimate
Valuation estimate
Validation Partners leadership team
Management profileNumber of profiles
Profiles5 records
Validation Partners funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Validation Partners M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Validation Partners
What does Validation Partners do?
Validation Partners provides software validation, implementation, and consulting services for laboratory and blood bank information systems used by healthcare organizations. The core Total Validation Services offering covers test plan development, test script writing, and execution with comprehensive documentation, complemented by project management, data conversion, system implementation with training, SOP development, and technical writing services.
Is Validation Partners a public or private company?
Validation Partners is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Validation Partners founded?
Validation Partners was founded in 1997. It employs 1 to 10 people.
Where is Validation Partners based?
Validation Partners is headquartered in Ronkonkoma, United States, in the North America region.
How does Validation Partners make money?
Five revenue lines are on record. Validation Services are the primary driver. The others are project Management Services, data Conversion Services, system Implementation and Training and technical Writing and SOP Development.
Who are Validation Partners's main competitors?
Direct peers on record are ProPharma Group, BioTechLogic, ValSource and CSols. Broad incumbents are MasterControl, Sysmex America, IQVIA Laboratories / Q² Solutions and Haemonetics (BloodTrack / SafeTrace). Emerging players are Novatek International and Blue Mountain Quality Resources.
Does Validation Partners have an API?
No public API is recorded for Validation Partners.
What industry is Validation Partners in?
Validation Partners's product category is Healthcare Software Validation Services. Its primary akta.pro industry code is HLAGAJAI, Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs), with a secondary code of HLACAMAE, Blood Bank/Transfusion Medicine LIS. Its NAICS code is 54169 and its SIC code is 7370.